Inspections, Compliance, Enforcement, and Criminal Investigations
Pacific Nutritional Foods, Inc. 10/9/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
October 9, 2009
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 10-02
Thomas H. Hiatt, President
Pacific Nutritional Foods, Inc.
9960 SW Potano Street
Tualatin, Oregon 97062
Dear Mr. Hiatt:
We inspected your food processing facility, located at 9960 SW Potano Street, Tualatin, Oregon, on June 30 and July 1, 2, 6, 7, 8, 9, 10, and 23, 2009. We found that you have serious violations of the Low-acid Canned Food (LACF) regulations, Title 21, Code of Federal Regulations, Parts 113 and 108 (21 CFR 113 &108). Failure to comply with the significant LACF requirements of Part 113 and 108, renders the LACF products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). Accordingly, your soy and oat based beverage products are adulterated, in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health.
You may find the Act and the LACF regulation through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. Your system, equipment, and procedures used for thermal processing of foods in hermetically sealed containers were not operated and administered in a manner that ensures commercial sterility is achieved, to comply with 21 CFR 113.40(j). Specifically, in January and February 2009, your firm received consumer complaints of spoilage in your Select Soy Low Fast Vanilla beverage. As a follow-up to this incident, your firm conducted microbiological tests on retained samples of Select Soy Low Fat Vanilla beverage manufactured on October 7, 2008, and found that the product were contaminated with Lactobacillus and Streptococcus.
According to your September 28, 2009, written response to the FDA 483, the product contamination was caused by a failure of an equipment component, (b)(4) such a Your response states that you will establish an SOP that spells out the proper course of action for such occurrence. We will verify this correction during our next inspection of your facility.
2. As a commercial processor engaged in thermal processing of low-acid foods packaged in hermetically sealed containers you must promptly report to the Food and Drug Administration any instance wherein any lot of such food, which may be injurious to health by reason of contamination with microorganisms, has in whole or in part entered distribution, to comply with 21 CFR 108.35(e). However, you failed to notify FDA about an instance of microbiological contamination, which may have caused a lot to be injurious to health, when consumer complaints of product spoilage received January and February 2009, revealed that Pacific Natural Foods Barista Series Soy Blenders Vanilla (32 oz.), manufactured on October 7, 2008, and subsequently released for distribution, was contaminated with microorganisms. Pacific Natural Foods Barista Series Soy Blenders Vanilla (32 oz.) was withdrawn from distribution in February 2009; however, FDA was not notified by you of the contamination or the product withdrawal. In addition, microbiological testing conducted March 3, 2009, of retained samples of Select Soy Low Fat Vanilla beverage manufactured on October 7, 2008, and subsequently released for distribution, found that the product was contaminated with microorganisms as well; however, FDA was not notified by you of the contamination.
3. You must have your scheduled processes for all low-acid foods established by a qualified person having expert knowledge of thermal processing requirements for low-acid foods in hermetically sealed containers and having adequate facilities for making such determinations, to comply with 21 CFR 113.83. However, you failed to have scheduled processes for your oat low acid beverage products established by qualified persons having expert knowledge of thermal processing as evidenced by the lack of written documentation showing scheduled processes delineating all critical factors for aseptic processing of these products through the UHT (b)(4) system including your Organic Oat Low Fat Original and Organic Oat Low Fat Vanilla.
4. As a commercial processor engaged in the thermal processing of low-acid foods packaged in hermetically sealed containers you must, not later than 60 days after registration and prior to the packing of a new product, provide the Food and Drug Administration information as to the scheduled processes including but not limited to the processing method, type of retort or other thermal processing equipment employed, minimum initial temperatures, times and temperatures of processing, sterilizing value, or other equivalent scientific evidence of process adequacy, critical control factors affecting heat penetration, and source and date of the establishment of the process, for each such low-acid food in each container size, to comply with 21 CFR 108.35(c)(2). However, you have not filed processes with FDA for a number of low acid beverage products, some of which you have manufactured since July 2008. The products include Organic Oat Low Fat Original and Organic Oat Low Fat Vanilla.
In addition, your (b)(4) products were produced on March 20 and 24, 2009, and were subsequently distributed; however, your initial FDA process file submission for these products is dated 5/28/09.
Scheduled process information for low-acid foods must be submitted on Form FDA 2541a (Processing Filing for all Processing Methods Except Low Acid Aseptic). More information on registration and filing can be found in the publication "Instructions for Establishment Registration and Processing Filing for Acidified and Low-Acid Canned Foods," available at: http://www.cfsan.fda.gov/~comm/lacf-s1.html
5. As a commercial processor of low-acid foods utilizing aseptic processing and packaging systems you must maintain records of container and/or closure sterilization, sterilization cycle times and temperatures, to comply with 21 CFR 113.100(a)(4). However, you failed to keep such records as evidenced by the (b)(4) bulk filler (Line (b)(4) strip chart for tofu puree bulk filling on September 29, 2008, which does not show fitment sterilization cycles during filling operations from 8:09 a.m. to 4:13 p.m.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation such as SOPs or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations. We recognize that you responded to the FDA 483 on September 28, 2009. However, your response did not include documentation of corrective actions, such as your updated SOPs. We will verify your corrective actions during our next inspection.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and the Low-acid Canned Food regulations, Parts 113 and 108. You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your written reply to the Food and Drug Administration, Attention: Michael J. Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, WA 98021-4421. If you have any questions regarding this letter, please contact Mr. Donovan at (425) 483-4906.
Charles M. Breen